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NCT02684591 · ClinicalTrials.gov registry record · Phase 2
Aramchol for HIV-associated Nonalcoholic Fatty Liver Disease and Lipodystrophy
A Phase 2 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT02684591: Completed Phase 2 study, sponsored by University of California, San Diego.
NCT02684591 is a Phase 2 study that has completed, run by University of California, San Diego. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02684591, a Phase 2 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
A subset of patients with NAFLD that have not been extensively studied are those infected with human immunodeficiency virus (HIV). Currently, there is no FDA approved treatment for NAFLD or NASH. Additionally, there have been no significant clinical trials for HIV patients with NAFLD and there are no approved treatment options. We plan to conduct a randomized, double-blinded, placebo-controlled clinical trial to examine the efficacy of 600 mg of Aramchol daily (including 200 mg tablet and 400 mg tablet) versus identical placebo given over 12 weeks to improve HIV-associated hepatic steatosis as measured by a validated and accurate magnetic resonance imaging (MRI)-based technique.
Primary Outcome
To examine the efficacy of aramchol at 600 mg orally daily versus placebo in improving hepatic steatosis assessed by magnetic resonance imaging in patients with HIV-associated NAFLD
Interventions
- DRUG Placebo
- DRUG Aramchol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2016-01 |
| Est. Completion | 2018-02 |
| Phase | Phase 2 |
What the finished NCT02684591 record still lists
NCT02684591 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02684591 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02684591 about?
NCT02684591 is a clinical study titled "Aramchol for HIV-associated Nonalcoholic Fatty Liver Disease and Lipodystrophy". A subset of patients with NAFLD that have not been extensively studied are those infected with human immunodeficiency virus (HIV). Currently, there is no FDA approved treatment for NAFLD or NASH. Additionally, there have been no significant clinical trials for HIV patients with NAFLD and there are n...
What is the current status of trial NCT02684591?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2016-01. Estimated completion is 2018-02.
What interventions are being tested in trial NCT02684591?
The interventions under investigation include: Placebo (DRUG), Aramchol (DRUG).
Who is sponsoring clinical trial NCT02684591?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02684591's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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